This clinical trial is focused on studying the effects of a medication called upadacitinib in combination with topical corticosteroids for treating individuals with moderate to severe atopic dermatitis, commonly known as eczema. Atopic dermatitis is a skin condition that causes red, itchy, and inflamed skin. The study aims to evaluate the safety and effectiveness of this treatment combination in adolescents and adults who may need systemic therapy, which involves medication that works throughout the entire body.
Participants in the study will receive either the medication upadacitinib, which is a Janus kinase (Jak) 1 inhibitor, or a placebo, along with topical corticosteroids. Topical corticosteroids are creams or ointments applied directly to the skin to reduce inflammation and itching. The study will last for several weeks, during which the participants’ skin condition will be monitored to see if there is an improvement in their eczema symptoms.
The goal of the study is to determine if the combination of upadacitinib and topical corticosteroids can effectively reduce the severity of eczema symptoms and improve the quality of life for those affected by this condition. The study will also assess the long-term safety of using upadacitinib over a period of up to 10 years. Participants will be regularly evaluated to track their progress and any changes in their condition.
1joining the study
Upon joining the study, eligibility is confirmed based on criteria such as age (12-75 years) and the presence of moderate to severe atopic dermatitis.
Participants must be candidates for systemic therapy or have recently required it for atopic dermatitis.
2initial assessment
An initial assessment is conducted to establish baseline measurements using scales like the Eczema Area Severity Index (EASI) and the Investigator’s Global Assessment (IGA).
The severity of itching is also measured using the Worst Pruritus Numerical Rating Scale (NRS).
3treatment phase
Participants receive upadacitinib in combination with topical corticosteroids. Upadacitinib is administered orally as a modified-release tablet.
Topical corticosteroids such as pimecrolimus, tacrolimus, triamcinolone, fluocinolone acetonide, and hydrocortisone are applied to the skin.
The treatment aims to assess the efficacy and safety of the combination over a period of 16 weeks.
4evaluation at week 16
At week 16, the primary goal is to determine the proportion of participants achieving a significant reduction in symptoms, as measured by the vIGA-AD and EASI 75 scales.
Secondary outcomes include improvements in itching and further reductions in EASI scores.
5long-term follow-up
The study includes a long-term follow-up to evaluate the safety and effectiveness of upadacitinib over a period of up to 10 years.
Participants continue to be monitored for any changes in their condition and response to treatment.
Who Can Join the Study?
Participants must be male or female and between 12 to 75 years old.
Participants should have active moderate to severe atopic dermatitis. This is a skin condition that causes red, itchy, and inflamed skin. It is measured by specific tools like EASI (Eczema Area and Severity Index), IGA (Investigator’s Global Assessment), BSA (Body Surface Area), and pruritus (itchiness).
Participants must be candidates for systemic therapy. This means they need treatment that affects the whole body, not just the skin, or they have recently needed such treatment for their atopic dermatitis.
Participants must be able to tolerate topical corticosteroids. These are creams or ointments applied to the skin to reduce inflammation and treat atopic dermatitis lesions.
Who Cannot Join the Study?
Patients who have a history of severe allergic reactions to any of the study medications.
Patients who are currently participating in another clinical trial.
Patients with a history of certain types of cancer.
Patients with active infections that require treatment.
Patients who are pregnant or breastfeeding.
Patients with a history of certain heart conditions.
Patients with liver disease or abnormal liver function tests.
Patients with a history of blood disorders.
Patients who have received certain vaccines recently.
Patients with a history of drug or alcohol abuse.
Patients who have used certain medications recently that might interfere with the study.
Patients with any other medical condition that the study doctors think might make it unsafe for them to participate.
Upadacitinib is a medication being studied for its effectiveness and safety in treating moderate to severe atopic dermatitis, a type of eczema. It is used in combination with topical corticosteroids to help reduce inflammation and improve skin condition in adolescents and adults who need systemic therapy. The study aims to evaluate both the short-term and long-term benefits of using upadacitinib for this skin condition.
Topical Corticosteroids are creams or ointments applied directly to the skin to reduce inflammation and relieve symptoms of atopic dermatitis, such as itching and redness. In this study, they are used alongside upadacitinib to enhance the treatment’s effectiveness for individuals with moderate to severe eczema.
Atopic Dermatitis – Atopic dermatitis is a chronic skin condition characterized by dry, itchy, and inflamed skin. It often begins in childhood but can occur at any age. The disease tends to flare periodically and then subside, with symptoms varying from mild to severe. Commonly affected areas include the face, neck, and the insides of the elbows, knees, and ankles. The exact cause is unknown, but it is believed to involve a combination of genetic and environmental factors. It is often associated with other allergic conditions like asthma and hay fever.
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